The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Resuscitation Valve.
| Device ID | K832868 |
| 510k Number | K832868 |
| Device Name: | RESUSCITATION VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | BOEHRINGER LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-24 |
| Decision Date | 1983-09-26 |